NRG-CC013: A Randomized, Masked, Placebo Controlled, Phase II Trial Of Concurrent Chemoradiation With Bmx-001 In Patients With Head And Neck Squamous Cell Carcinoma Receiving Concurrent Chemoradiation
Objective
Primary Objective To compare the incidence of severe oral mucositis (SOM) between BMX-001 and placebo, defined as ≥ Grade 3 per WHO criteria from the start of radiation through 4 weeks after completion of study treatment, with additional assessments at 6, 8 and 12 weeks after completion of study treatment.
Secondary Objectives To compare the duration of SOM in the BMX-001 arm vs. placebo arm. To assess the difference between arms in the OMWQ-HN change score from baseline to 4 weeks after the end of chemoradiation. To describe the incidence and severity of xerostomia and radiation dermatitis, as measured by CTCAE v5.0, in both arms. To compare the duration of radiation dermatitis in the BMX-001 arm vs. placebo arm. To describe toxicity, as measured by CTCAE v5.0 and PRO-CTCAE, in both arms.
Exploratory Objectives To assess the between arm difference in progression-free survival (PFS). To assess the between arm difference in overall survival (OS). Data demonstrating improvement in pain, as measured by reduction in narcotic use between BMX-001 versus usual care. Collect serum and plasma for future translational research analyses
